Type 2 Diabetes Mellitus (T2DM)MACBIPARTFCGNCT07495020
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
A study testing Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication, Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy and laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy in people with Type 2 Diabetes Mellitus (T2DM) and Obesity & Overweight, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
Trial summary
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion
- What is being tested?
- Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication, Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy and laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteKazakhstan
- Study dates
- 30 Apr 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes Mellitus
- BMI 25-35 kg/m2
Who cannot join
- Insulin dependent diabetes
- BMI <25 and >35 kg/m2
- History of surgery on the stomach
- Less than 18 or more than 65 years of age
- Psychiatric illness
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bakhtiyar Yelembayev contact
Kazakhstan1 site, 1 recruiting
- Recruiting
Oral Ospanov
Astana, 010000
Oral Ospanov, +77015287734, bariatric.kz@gmail.com
About this study
Official title: The Laparoscopic Transit Bipartition Without Gastrectomy With Use of Metallic Anastomosis Clip (MAC) and Circular Fundocorporeal Gastroplication for Treating Type 2 Diabetes Mellitus and Obesity
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²).
Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation.
Read more
The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs.
Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.
Read the detailed description
Background:
Type 2 diabetes mellitus (T2DM) is a major global health burden characterised by progressive micro- and macrovascular complications despite pharmacological management. Bariatric and metabolic surgery (BMS) has demonstrated superiority over conservative therapy in achieving durable T2DM remission, primarily through incretin-mediated and weight-independent mechanisms. However, standard BMS indications (BMI ≥35 kg/m²) exclude the majority of T2DM patients who present with overweight or Class I obesity (BMI 25-34.9 kg/m²).
Transit bipartition (the "dual-path" procedure) offers a promising alternative: it preserves the natural duodenal alimentary route while creating an additional gastro-ileal bypass with an entero-enteric anastomosis, thereby stimulating GLP-1 secretion and restoring the incretin effect without the malabsorptive consequences of gastric bypass. This eliminates the need for lifelong micronutrient supplementation.
Device:
The Metallic Anastomotic Clip (MAC) is an authors' proprietary compression anastomotic device developed for laparoscopic creation of bypass gastroenteroanastomosis and entero-enteric anastomosis. The device applies controlled radial compression to achieve tissue approximation and anastomotic healing without sutures or staples. A preliminary pilot study in 10 patients demonstrated technical feasibility and safety.
Study Design:
Prospective, randomised controlled trial (RCT) with three parallel arms:
Group 1: laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip) with circular fundocorporeal gastroplication (without gastrectomy) Group 2: laparoscopic transit bipartition (gastro-ileal anastomosis and entero-enteric anastomosis) using the Metallic Anastomotic Clip with sleeve gastrectomy Group 3: laparoscopic duodenal transit bipartition (single duodenoileal anastomosis) using the Metallic Anastomotic Clip sleeve gastrectomy
Primary Outcomes: HbA1c, fasting glucose, HOMA-IR, remission rate of T2DM (per 2021 ADA/EASD/IFSO consensus criteria) at 12 and 24 months;
Secondary Outcomes:
Anastomotic complication rate (leak, bleeding, stricture, marginal ulcer). BMI, quality of life, operative time, length of hospital stay, morbidity and mortality.
Setting: Surgical Centre of Professor Oral Ospanov, Astana, Kazakhstan. Regulatory: The study will be conducted in accordance with GCP guidelines and the Declaration of Helsinki. The Metallic Anastomotic Clip device will be protected by a utility model patent.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic
- Being tested
- Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication, Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy, laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy
- Keywords
- Metallic Anastomotic Clip, Metabolic bariatric surgery, obesity, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Peptic Ulcer, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal GastroplicationProcedure or surgery
The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomyProcedure or surgery
A calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomyProcedure or surgery
The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus.
The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side).
| Study group | Role | What they receive |
|---|---|---|
| MAC_transit bipartition with circular fundocorporeal gastroplication | Experimental | Group 1: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis and enteroenterostomy) using the Metallic Anastomotic Clip and with circular fundocorporeal gastroplication without gastrectomy Receives: Procedure: Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication |
| MAC_transit bipartition with sleeve gastrectomy | Experimental | Group 2: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis + enteroenterostomy) use Metallic Anastomotic Clip with sleeve gastrectomy Receives: Procedure: Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy |
| MAC_duodenal transit bipartition with circular fundocorporeal gastroplication | Experimental | Group 3: 30 patients with laparoscopic duodenal transit bipartition use Metallic Anastomotic Clip with circular fundocorporeal gastroplication Receives: Procedure: laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2DM remission rate
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
Measured: Baseline, 1, 2, 3 year after surgery
Secondary outcomes (2)
Change of body mass index
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2
Measured: Baseline, 1, 2, 3 year after surgery
Anastomotic complication rate
leak, bleeding, stricture, marginal ulcer
Measured: <30 day after surgery, 1, 2, 3 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
- Sponsor type
- University, hospital or other
- Collaborators
- Astana Medical University
- Responsible party
- Sponsor
- Investigators
- Oral Ospanov, Professor, Principal investigator, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495020
- Sponsor's protocol ID
- MAC-BIPART-FCG
- Acronym
- MACBIPARTFCG
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laparoscopic Transit Bipartition Without Gastrectomy With Use of Metallic Anastomosis Clip (MAC) and Circular Fundocorporeal Gastroplication for Treating Type 2 Diabetes Mellitus and Obesity
- ClinicalTrials.gov ID
- NCT07495020
- Acronym / sponsor ID
- MACBIPARTFCG / MAC-BIPART-FCG
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic
- Keywords
- Metallic Anastomotic Clip, Metabolic bariatric surgery, obesity, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
- Collaborators
- Astana Medical University
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²).
Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation.
The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs.
Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.
Detailed description
Background:
Type 2 diabetes mellitus (T2DM) is a major global health burden characterised by progressive micro- and macrovascular complications despite pharmacological management. Bariatric and metabolic surgery (BMS) has demonstrated superiority over conservative therapy in achieving durable T2DM remission, primarily through incretin-mediated and weight-independent mechanisms. However, standard BMS indications (BMI ≥35 kg/m²) exclude the majority of T2DM patients who present with overweight or Class I obesity (BMI 25-34.9 kg/m²).
Transit bipartition (the "dual-path" procedure) offers a promising alternative: it preserves the natural duodenal alimentary route while creating an additional gastro-ileal bypass with an entero-enteric anastomosis, thereby stimulating GLP-1 secretion and restoring the incretin effect without the malabsorptive consequences of gastric bypass. This eliminates the need for lifelong micronutrient supplementation.
Device:
The Metallic Anastomotic Clip (MAC) is an authors' proprietary compression anastomotic device developed for laparoscopic creation of bypass gastroenteroanastomosis and entero-enteric anastomosis. The device applies controlled radial compression to achieve tissue approximation and anastomotic healing without sutures or staples. A preliminary pilot study in 10 patients demonstrated technical feasibility and safety.
Study Design:
Prospective, randomised controlled trial (RCT) with three parallel arms:
Group 1: laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip) with circular fundocorporeal gastroplication (without gastrectomy) Group 2: laparoscopic transit bipartition (gastro-ileal anastomosis and entero-enteric anastomosis) using the Metallic Anastomotic Clip with sleeve gastrectomy Group 3: laparoscopic duodenal transit bipartition (single duodenoileal anastomosis) using the Metallic Anastomotic Clip sleeve gastrectomy
Primary Outcomes: HbA1c, fasting glucose, HOMA-IR, remission rate of T2DM (per 2021 ADA/EASD/IFSO consensus criteria) at 12 and 24 months;
Secondary Outcomes:
Anastomotic complication rate (leak, bleeding, stricture, marginal ulcer). BMI, quality of life, operative time, length of hospital stay, morbidity and mortality.
Setting: Surgical Centre of Professor Oral Ospanov, Astana, Kazakhstan. Regulatory: The study will be conducted in accordance with GCP guidelines and the Declaration of Helsinki. The Metallic Anastomotic Clip device will be protected by a utility model patent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAC_transit bipartition with circular fundocorporeal gastroplication | Experimental | Procedure: Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal GastroplicationGroup 1: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis and enteroenterostomy) using the Metallic Anastomotic Clip and with circular fundocorporeal gastroplication without gastrectomy |
| MAC_transit bipartition with sleeve gastrectomy | Experimental | Procedure: Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomyGroup 2: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis + enteroenterostomy) use Metallic Anastomotic Clip with sleeve gastrectomy |
| MAC_duodenal transit bipartition with circular fundocorporeal gastroplication | Experimental | Procedure: laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomyGroup 3: 30 patients with laparoscopic duodenal transit bipartition use Metallic Anastomotic Clip with circular fundocorporeal gastroplication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 Diabetes Mellitus
- BMI 25-35 kg/m2
Key exclusion criteria (6 listed)
- Insulin dependent diabetes
- BMI <25 and >35 kg/m2
- History of surgery on the stomach
- Less than 18 or more than 65 years of age
- Psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal GastroplicationThe procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip. | Procedure or surgery | MAC_transit bipartition with circular fundocorporeal gastroplication |
| Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomyA calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip. | Procedure or surgery | MAC_transit bipartition with sleeve gastrectomy |
| laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomyThe procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus. The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side). | Procedure or surgery | MAC_duodenal transit bipartition with circular fundocorporeal gastroplication |
Primary outcome
T2DM remission rate
Time frame: Baseline, 1, 2, 3 year after surgery
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
2 secondary outcomes
Change of body mass index
Time frame: Baseline, 1, 2, 3 year after surgery
Anastomotic complication rate
Time frame: <30 day after surgery, 1, 2, 3 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bakhtiyar Yelembayev contact
Oral Ospanov, Professor principal investigator
Astana Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication, Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy and laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy in people with Type 2 Diabetes Mellitus (T2DM) and Obesity & Overweight, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oral Ospanov (Astana, Kazakhstan, 010000, bariatric.kz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2DM remission rate (time frame: Baseline, 1, 2, 3 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.